Circadian Thermal Sensing for the Detection of Breast Disease as a Supplemental Cancer Screening System

Purpose:

The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™),
which is attached to soft biometric patches worn on the body, can improve early breast
cancer detection along with mammography or as a stand alone device.

Study summary:

The Cyrcadia CBR™ (Circadian Biometric Recorder) includes wearable biometric patches and a
detachable data recording device. The CBR™ records chronobiologic data while the patient is
totally ambulatory and going about her normal daily routine. Following removal of the
detachable data recording device from the wearable biometric patches, the data is
transferred to a computer for analysis. The Cyrcadia CBR™ will be placed on the patient for
the duration of 2 to 24 hours. There is no restriction of daily activity. The study subject
is requested to sponge bathe rather than shower while wearing the device, keeping the device
dry during the testing procedure. After this period, the CBR™ will be removed and the data
will be transferred to a computer for analysis.
The primary endpoint of this 173 patient study is to determine the accuracy of Cyrcadia CBR™
as a supplemental screening device to mammography and ultrasound in predicting a diagnosis
of breast cancer. Specific emphasis will be on the utilization of the CBR as a secondary
screening device to reduce the number of biopsies currently performed on non-cancerous
tissue. A secondary emphasis will be on the CBR to act as an improved screening solution
over mammography specifically in those patients with dense breast parenchymal tissue.
Other endpoints of the study are:
- to determine the accuracy of Cyrcadia CBR™, including the positive predictive value,
negative predictive value, false negative rate and false positive rate.
- to determine the optimal wear time for the Cyrcadia CBR™.
- to demonstrate substantial equivalent or improved results when applied to Cyrcadia
original patient case study with identical advanced neural network analysis
computational results.
Study subjects will be followed at 6, 12, 18, and 24 months to update their clinical status.

Criteria:

Inclusion Criteria:
- Women with a BI-RADS category 4 or 5 designation on mammogram
- Women with a BI-RADS category 4 or 5 designation on breast ultrasound
- Women with a BI-RADS category 4 or 5 designation on breast MRI
- Women who are willing to undergo a complete evaluation and/or biopsy procedure if
recommended by the treating physician
Exclusion Criteria:
- Less than 21 years of age
- Unable to sign the consent form
- Pregnant or lactating
- Physically unable to wear the Cyrcadia CBR™ for 24 hours
- Previous mastectomy
- Any breast surgery or biopsy within the last 90 days
- Any trauma to the breast within the last 90 days
- Any biopsy or treatment for the BI-RADS category 4 or 5 abnormality
- Refusal to undergo recommended diagnostic evaluation of the BI-RADS category 4 or 5
abnormality